Clinical Trials Logo
  1. Home
  2. Chronic Hepatitis B
  3. NCT06368882

Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）

Chronic Hepatitis b Clinical Trial

Official title:
Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）

Clinical Trial Summary

This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease. A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly. The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up. The security assessment includes adverse events, vital signs, and imaging.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06368882
Study type Interventional
Source First Affiliated Hospital of Wenzhou Medical University
Contact Yongping Chen, Professor
Phone 13505777281
Email 13505777281@163.com
Status Recruiting
Phase Phase 4
Start date January 1, 2024
Completion date December 31, 2028
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04496882 - Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue Phase 4
Completed NCT04083716 - A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults Phase 1
Not yet recruiting NCT03038802 - A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection Phase 1/Phase 2
Completed NCT05310487 - Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects Phase 1
Recruiting NCT06070051 - Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy Phase 1
Terminated NCT05001022 - A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects Phase 1
Recruiting NCT04139850 - The Establishment of Korean Hepatitis B Patients Cohort
Recruiting NCT05343481 - Efficacy of VTP-300 in Chronic Hepatitis B Infection Phase 2
Not yet recruiting NCT05490836 - Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients N/A
Recruiting NCT04543565 - Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study Phase 3
Active, not recruiting NCT02894918 - A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs Phase 4
Not yet recruiting NCT02793791 - Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients N/A
Recruiting NCT02287857 - Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B N/A
Recruiting NCT01965418 - A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial Phase 4
Recruiting NCT01491295 - Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Phase 4
Terminated NCT01872988 - Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma Phase 3
Recruiting NCT01487876 - Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients Phase 2
Completed NCT01531166 - A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon N/A
Not yet recruiting NCT01436539 - Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients Phase 4
Recruiting NCT01360892 - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography N/A